Wockhardt moves HC against ban on its fixed dose combination drug

Wockhardt moved the court as its anti-inflammatory drug -- Ace Proxyvon -- is one of the FDC medicines affected by the Centre's September 7 notification banning 328 such combinations

PTI|

Sep 14, 2018, 06.08 PM IST

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Besides the latest notification, the Health Ministry, had prohibited 349 FDCs for manufacture, sale and distribution in March 2016.

A week after the Centre banned the manufacturing, sale and distribution of 328 fixed dose combination (FDC) drugs, Indian pharma major Wockhardt Friday moved the Delhi High Court against the Health Ministry's decision. The petition by Wockhardt was mentioned before a bench of Justices S Ravindra Bhat and A K Chawla, which allowed it to be listed for hearing today.

However, when the court rose at 5.00 PM, the petition file had not reached the designated bench till then from the high court's registry which is entrusted with the task of listing of the matters.

Wockhardt moved the court as its anti-inflammatory drug -- Ace Proxyvon -- is one of the FDC medicines affected by the Centre's September 7 notification banning 328 such combinations. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.

Ace Proxyvon, which is sold by the company in a tablet form, is a mixture of three salts -- aceclofenac, paracetamol and rabeprazol -- a combination which is banned.

The pharma company, which claims to have been manufacturing and selling the drug for 11 years now, contended that it has not been provided with the Drugs Technical Advisory Board (DTAB) report, based on which the decision was taken.

It claimed that the only reason given in the September 7 notification was that the combination has no therapeutic value.

The medicine is reportedly prescribed for people with painful rheumatic conditions, such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Besides the latest notification, the Health Ministry, through a notification of March 10, 2016, had prohibited 349 FDCs for manufacture, sale and distribution under Section 26 A of the Drugs and Cosmetics Act, 1940. The notification was then contested by the pharma companies in the Delhi High Court and the Supreme Court.

The high court in December 2016 had quashed the ban on the FDCs, which was challenged by the Centre in the apex court.

The top court had in December last year set aside the high court order and referred the banned FDCs to DTAB for re-examination.

Complying with the apex court direction, an expert panel formed by DTAB, in its report to the Centre, had stated that there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, which may also involve risk to humans.

The Board had recommended that it was necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in larger public interest.